PharmacoEconomics (2015) 33:957–965
DOI 10.1007/s40273-015-0280-0
ORIGINAL RESEARCH ARTICLE
Exploring the Use of Cost-Benefit Analysis to Compare
Pharmaceutical Treatments for Menorrhagia
Sabina Sanghera1,4 • Emma Frew1 • Janesh Kumar Gupta2 • Joe Kai3
Tracy Elizabeth Roberts1
Published online: 25 April 2015
Ó The Author(s) 2015. This article is published with open access at Springerlink.com
Abstract
Background The extra-welfarist theoretical framework
tends to focus on health-related quality of life, whilst the
welfarist framework captures a wider notion of well-being.
EQ-5D and SF-6D are commonly used to value outcomes
in chronic conditions with episodic symptoms, such as
heavy menstrual bleeding (clinically termed menorrhagia).
Because of their narrow-health focus and the condition’s
periodic nature these measures may be unsuitable. A viable
alternative measure is willingness to pay (WTP) from the
welfarist framework.
Objective We explore the use of WTP in a preliminary
cost-benefit analysis comparing pharmaceutical treatments
for menorrhagia.
Methods A cost-benefit analysis was carried out based on
an outcome of WTP. The analysis is based in the UK
Electronic supplementary material The online version of this
article (doi:10.1007/s40273-015-0280-0) contains supplementary
material, which is available to authorized users.
& Emma Frew
E.Frew@bham.ac.uk
1
Health Economics Unit, Public Health Building, University
of Birmingham, Edgbaston, Birmingham B15 2TT, UK
2
School of Clinical and Experimental Medicine, University of
Birmingham, Birmingham, UK
3
Division of Primary Care and National Institute for Health
Research, University of Nottingham, Nottingham, UK
4 The cost-benefit analysis suggests oral treatment as a
Present Address: Health Economics Research Group, Brunel
University London, Uxbridge UB8 3PH, UK
•
primary care setting over a 24-month time period, with a
partial societal perspective. Ninety-nine women completed
a WTP exercise from the ex-ante (pre-treatment/condition)
perspective. Maximum average WTP values were elicited
for two pharmaceutical treatments, levonorgestrel-releas-
ing intrauterine system (LNG-IUS) and oral treatment.
Cost data were offset against WTP and the net present
value derived for treatment. Qualitative information ex-
plaining the WTP values was also collected.
Results Oral treatment was indicated to be the most cost-
beneficial intervention costing £107 less than LNG-IUS
and generating £7 more benefits. The mean incremental net
present value for oral treatment compared with LNG-IUS
was £113. The use of the WTP approach was acceptable as
very few protests and non-responses were observed.
Conclusion The preliminary cost-benefit analysis results
recommend oral treatment as the first-line treatment for
menorrhagia. The WTP approach is a feasible alternative to
the conventional EQ-5D/SF-6D approaches and offers ad-
vantages by capturing benefits beyond health, which is
particularly relevant in menorrhagia.
Key Points for Decision Makers
Menorrhagia affects health and non-health aspects of
life
Broader benefits of the treatment should also be
considered
Willingness to pay is feasible and acceptable for use
in menorrhagia
first-line treatment for menorrhagia
958 S. Sanghera et al.

1 Introduction economic evaluation of these pharmaceutical treatments

for menorrhagia was conducted alongside a trial using both
EQ-5D and SF-6D to compare levonorgestrel-releasing
Economic evaluation offers a formal toolkit to assess both
intrauterine system (LNG-IUS) with usual medical treat-
the costs and consequences of competing services. In the
ment as first-line treatment for menorrhagia [6]. LNG-IUS
UK, decision makers such as the National Institute for
is an intrauterine device that can be inserted by the general
Health and Care Excellence (NICE) have adopted cost-
practitioner (GP) and also provides contraception. Usual
utility analysis as the economic evaluation method of
medical treatment can include one of the following:
choice, which measures outcomes using quality-adjusted
tranexamic acid, mefenamic acid, norethisterone, depo-
life-years (QALYs) with a focus on health-related out-
provera, or combined estrogen/progestogen or progesto-
comes [1]. The conventional criterion for decision making
gen-only oral contraceptive pill (any formulation), which is
is based on a health-maximisation principle with the aim of
prescribed by the GP (a description of each treatment is
maximising QALYs relative to the resources available.
presented in the online resource).
This approach to economic evaluation, with its focus on
Concerns around the use of these measures, which are
health outcomes, is described in theoretical terms as an
underpinned by the extra-welfarist perspective in menor-
‘extra-welfarist’ approach [2]. To construct QALYs, it is
rhagia, were highlighted as the treatment recommendation
recommended that either the EQ-5D or the SF-6D instru-
to decision makers differed depending on the measure used
ment is used to measure health-related quality of life. The
to generate the QALY [6]. Despite being advocated by
use of cost-utility analysis offers a framework for evi-
decision makers, there is evidence to suggest that these
dence-based decision making in which the objective is to
measures, which focus on health, may not be suitable for a
maximise health, but it offers limited support for the
condition such as menorrhagia because women believe
evaluation of interventions for which there are gains that go
both health and non-health aspects of life are affected by
beyond health alone. Cost-benefit analysis is an alternative
the condition [7]. Furthermore, the standard recall periods
approach within the economic evaluation toolkit and in
of typically used measures and the episodic nature of the
contrast is based on the welfarist approach. Cost-benefit
condition also mean results could be affected by the timing
analysis places a monetary value on outcomes using stated
of assessment. This combined reasoning raises questions
preferences methods such as contingent valuation or
about the suitability of QALYs as an outcome measure.
‘willingness to pay’ (WTP). A cost-benefit analysis takes a
The WTP measure, underpinned by welfarist theory,
wider perspective compared with a cost-utility analysis and
enables the respondent to take into consideration both
thus offers the potential to incorporate costs and conse-
health and non-health outcomes and may overcome the
quences that go beyond the healthcare sector.
issue of timing of assessment. To demonstrate its feasi-
Measures used to capture outcomes underpinned by the
bility, we explore the use of the WTP approach in a pre-
extra-welfarism framework are commonly used across all
liminary cost-benefit analysis to assess the cost
types of clinical conditions, including those that are
effectiveness of LNG-IUS compared with usual medical
chronic but have symptoms that occur in episodes [3]. One
treatment (also referred to as oral treatment) as the first-line
such condition is heavy menstrual bleeding, which is
treatment for menorrhagia.
clinically termed ‘menorrhagia’. Menorrhagia can be de-
fined as ‘‘excessive menstrual blood loss which interferes
with the woman’s social, emotional, physical and material
2 Methods
quality of life’’ [4]. The principal driver for treatment is
based on women’s experience of its interference in their
A cost-benefit analysis was carried out based on an out-
lives [5]. An objective measure of volume of blood loss is
come of WTP. The analysis is related to the UK primary
therefore no longer considered to be suitable, and it is a
care setting and provides an assessment of the difference in
woman’s subjective assessment of her ability to cope and
costs and WTP between interventions over a 24-month
the perceived impact on her quality of life that is increas-
time horizon. The reporting of the cost-benefit analysis
ingly used to assess treatment success [5]. As impact on
follows the CHEERS guidelines [8].
quality of life is the key indicator of treatment success, it is
important to ensure that the quality-of-life measure is used
accurately to reflect women’s concerns and experiences. 2.1 Participants and Study Design
Historically, women had surgery to treat menorrhagia;
however, non-hormonal and hormonal pharmaceutical For this exploratory study, a convenience sample of 110
treatments are now available as first-line treatment for women were recruited from general gynaecology outpa-
women with menorrhagia. The first robust, UK-based tient clinics based in the Birmingham Women’s Hospital
Exploring Cost-Benefit Analysis in Menorrhagia
between December 2012 and January 2013. Women who
were menstruating but did not necessarily have experience
of menorrhagia or its treatments were sought, so all women
attending an appointment were approached to complete a
booklet questionnaire, either in the clinic or at home, and
provided written informed consent to participate. Respon-
dents who took the questionnaire home to complete were
given a stamped addressed envelope. Women were asked
to value the two pharmaceutical treatments of LNG-IUS
and oral treatment.
2.2 Outcome Measures
WTP is elicited from the ex-ante perspective. Individuals
are asked to express in monetary terms how much they
value a good or a service that leads to a change in outcome
[9]. In this context, maximum WTP values were derived
prior to the change in outcome occurring, from respondents
who are ‘at risk’ of the condition, or ‘at risk’ of requiring
treatment. Given the UK is a tax-funded system that offers
healthcare ‘free at the point of use’, we designed the WTP
study to elicit the views of the at-risk population. The ra-
tionale being that because society is funding the healthcare
system, it is the views of those at risk that should be sought.
The questionnaire booklet was reviewed by clinical
experts in menorrhagia, psychologists and health econo-
mists for face and content validity. Maximum WTP values
were elicited for both LNG-IUS and oral treatment using a
self-complete booklet questionnaire. The booklet captured
data on WTP and sociodemographic details.
A description of menorrhagia (without treatment) was
first presented and was based on the domains of the dis-
ease-specific quality-of-life Menorrhagia Multi-attribute
Assessment Scale (MMAS). This measure incorporates
both the health and non-health outcomes associated with
menorrhagia and consists of six attributes, ‘practical diffi-
culties, ‘social life’, ‘psychological health’, ‘physical
health and well-being’, ‘work/daily routine’ and ‘family
life/ relationships’ [10]. We used baseline MMAS data
from a recent trial (ECLIPSE, ISRCTN86566246) to gen-
erate the description. We then presented a scenario de-
scribing the expected average ‘outcome’ associated with
the two treatments, LNG-IUS (termed Mirena in the sce-
narios) and oral treatment, using average follow-up MMAS
data from the ECLIPSE trial [11].
Using the same method the scenarios for the outcomes
associated with LNG-IUS and oral treatments, using the
6-month ECLIPSE MMAS data, were generated. Infor-
mation describing the process of care was also described in
the treatment scenarios (see online resource for method
used for scenario development).
Respondents were asked for their preferred treatment,
and their maximum monthly out-of-pocket WTP value up
959
until menopause first for oral treatment, and then LNG-
IUS. A payment scale, which presents respondents with a
range of monetary values, was used to elicit WTP values as
it has a higher completion rate than other methods that can
be used in a postal questionnaire [12]. The payment scale
was derived from a previous applied WTP study [12], and
used a range from £0 to £500, which was considered to be
most suitable, as the questionnaire asked respondents to
provide a monthly WTP value. An open-ended option for
values greater than £500 was offered. Following the WTP
question, we asked respondents to outline the reasons for
their WTP values in an open-ended question to assess the
validity of the WTP responses. The respondents were then
asked to indicate whether they found the WTP question
difficult to answer, and to provide reasons for their re-
sponse. The time frame of payment ‘up until menopause’
was explicitly stated to ensure that WTP values were not
overestimated [13]. The questionnaire included a reminder
to consider the amount that they can afford to pay to ensure
that the responses obtained were realistic and within the
respondent’s means [14]. The time period was intuitive
given the nature of the condition. The monthly payment
time frame was used because women generally pay
monthly (or every 3 months) for prescriptions for menor-
rhagia, for sanitary protection and will experience the
benefits of treatment on a monthly basis.
The booklet questionnaire is presented in the online
resource.
2.3 Cost and Resource Use
Given that an ex-ante perspective was adopted, the women
were not typically being treated with LNG-IUS or oral
treatment, and therefore primary cost data were not avail-
able. The costs were consequently derived using the
ECLIPSE trial data as the most appropriate available
source and also to enable comparability between the cost-
utility analysis alongside the ECLIPSE trial and our cost-
benefit analysis [6]. Briefly, the general healthcare costs for
both treatments included healthcare staff costs and the cost
of the treatments. The costs of LNG-IUS and oral treatment
were estimated using the British National Formulary [15].
Staff costs were calculated using the nationally recognised
reference costs [16]. All costs are reported in 2011 prices in
UK (£) sterling using the UK hospital and community
health services index [16]. The overall costs for both LNG-
IUS and oral treatment at the 2-year time point in the
ECLIPSE trial included crossover between treatment arms,
as the analysis within the trial was ‘intention to treat’. The
average costs of LNG-IUS and oral treatment per person
were taken from the average results of a trial-based eco-
nomic evaluation, where a decision model was used as the
basis for the evaluation, and were reported to be £430 and
960
£330, respectively [6]. All costs are from a UK National
Health Service perspective. A societal perspective for costs
was considered but was not used to enable a comparison
between previous analyses using EQ-5D and SF-6D [6].
2.4 Analysis
Average maximum WTP values are compared to the cost
of providing the service to generate the net present value
(NPV) for each treatment option. If the present value of
benefits (expressed through WTP) outweighs the present
value of costs (present value of benefits - present value of
costs), then the net benefits are said to be positive
(NPV [ 0) and it is in society’s interest to recommend the
treatment choice. The treatment choice that yields the
maximum NPV is the most efficient.
The incremental net benefit that shows the difference
between the net benefits across the treatments (NPV oral
treatment - NPV LNG-IUS) is also presented. To adjust to
the present value, the recommended discount rate of 3.5 %
was applied to both the costs and outcomes [3]. The WTP
values derived for both LNG-IUS and oral treatment were
based on a monthly amount, to obtain the present value the
WTP value was discounted for every month up to and
including 24 months. WTP data were found to be non-
normal and were therefore log transformed [17]. A paired
t-test was then applied to the log transformed data to ex-
plore the difference between the WTP values for each
treatment. Protest answers and non-response were removed
from the analysis.
The base-case analysis is presented using the cost data
described above, which relates to the outcome of the eco-
nomic evaluation alongside the ECLIPSE trial [6] and is
based on an ‘intention-to-treat’ analysis. The base-case
analysis was carried out in addition to two sensitivity
analyses to assess uncertainty in the results.
Sensitivity analysis:
1. An assessment of uncertainty in the mean NPV is
carried out by bootstrapping. Bootstrapping involves
randomly sampling values, with replacement from the
observed values. Multiple samples are drawn, as 1000
bootstrap datasets are generated using STATA (Ver-
sion 11.0), and each dataset is considered to be a
reiteration of the trial [18]. Bootstrapped 95 % confi-
dence intervals around the mean values are presented
and the distributions of the bootstrapped values are
then presented graphically.
2. A second sensitivity analysis using alternative cost data,
which were not derived from the ECLIPSE model, was
applied to identify the impact of the source of cost data.
In this sensitivity analysis, the resource use and cost data
related to the exclusive use of either LNG-IUS or oral
S. Sanghera et al.
treatment are applied, treatment cross-over is not
considered. Table 1 outlines the cost data used in the
sensitivity analysis. As oral treatment comprises a range
of pharmaceutical treatments, the average cost of oral
treatment was weighted according to the frequency with
which each treatment is prescribed [6].
3 Results
3.1 Base-Case Results
The maximum average WTP for LNG-IUS was £365 and
for oral treatment was £372. This difference was not sta-
tistically significant (p = 0.1247; p \ 0.05). The max-
imum average WTP for oral treatment was 13 % higher
than the cost of the intervention, and the maximum average
WTP for LNG-IUS was 15 % lower than the cost of
treatment (Table 2).
The base-case results indicate that oral treatment pro-
vides a positive NPV of £45, resulting in a welfare gain,
and LNG-IUS produces a negative NPV of £-68, leading
to a welfare loss (Table 2). When comparing the two
treatments, the incremental net benefit exceeds zero sug-
gesting that oral treatment is cost beneficial compared with
LNG-IUS. Based on the mean values, oral treatment could
be considered the most cost-beneficial intervention.
3.2 Sensitivity Analysis
In sensitivity analysis 1, the confidence intervals associated
with the NPVs for both treatments overlap. The NPV is
£-68 [95 % CI £-186 to £50] for LNG-IUS and £45
[95 % CI £-55 to £146] for oral treatment. This suggests
there is some uncertainty between which treatment is most
cost beneficial. However, when presented using graphed
plots the bootstrapped NPV for LNG-IUS and oral treat-
ments show a clearer picture with respect to the welfare
gains and losses (Figs. 1, 2). In most cases, oral treatment
produces a positive NPV, as a greater proportion of the
bootstrapped NPV values lie above £0 (Fig. 1). In contrast,
the plots for LNG-IUS are the inverse of those for oral
treatment, as in most cases LNG-IUS produces a negative
NPV. These bootstrapped plots suggest that oral treatment
is more likely to be cost beneficial relative to LNG-IUS and
reinforce the base-case result.
In sensitivity analysis 2, the mean WTP for LNG-IUS is
41 % greater than the cost of LNG-IUS. The mean WTP for
oral treatment is 280 % greater than the cost of oral treatment
(Table 3). Both treatments generate a positive NPV.
The results still indicate that oral treatment remains the
most cost-beneficial treatment as it generates a greater
Exploring Cost-Benefit Analysis in Menorrhagia 961

Table 1 Cost data used in sensitivity analysis

Unit cost (£)a Source

LNG-IUS
Consultation (GP 10 min) 26.67 Curtis 2011 (16)/expert opinionb
Insertion
GP (20 min) 53.33 Curtis 2011 (16)/expert opinion
Practice nurse (20 min) 17.00 Curtis 2011 (16)/expert opinion
Device cost 88.00 BNF 62 (15)
Sterile pack (insertion) 21.63 NICE (4) (inflated to 2011)
Follow-up
6-week review: (GP 10 min) 26.67 Curtis 2011 (16)/expert opinion
3 month review: (GP 10 min) 26.67 Curtis 2011 (16)/expert opinion
a c
Unit cost (£) Frequency Source

Oral treatment
Progestogen (Cerazette) 8.68 21 BNF 62 (15)
Tranexamic acid (Cyclokapron) 14.30 19 BNF 62 (15)
Mefenamic acid (Ponstan) 15.72 8 BNF 62 (15)
Norethisterone 2.18 2 BNF 62 (15)
Combined oral contraceptive (Microgynon) 2.82 1 BNF 62 (15)
Methoxyprogesterone acetate injections (Depo-provera) 6.01 6 BNF 62 (15)
Consultation: (GP 10 min) 26.67 Curtis 2011 (16)/expert opinion
Review of medication (GP 10 min) 26.67 Curtis 2011 (16)/expert opinion

BNF British national formulary, GP general practitioner, LNG-IUS levonorgestrel-releasing intrauterine system, NICE National Institute for
Health and Care Excellence
a
The cost year is 2011
b
Expert opinion refers to clinical experts in menorrhagia (JG, JK)
c
The frequency is used to calculate the weighted average cost of oral treatment. The values are derived from data in a model-based economic
evaluation [6]

Table 2 Base-case results: Intervention WTP Cost NPV (WTP - cost) INB (NPV oral - NPV LNG-IUS)
mean WTP and cost of
treatment LNG-IUS £365 £433 £-68
Oral treatment £372 £326 £45 £113
Mean difference £-7 £107
Cost data are reported in UK (£) sterling and the cost year is 2011. Costs are rounded to the nearest whole
number
Cost data relate to the results of the economic evaluation alongside the ECLIPSE trial [6], which are based
on an ‘intention-to-treat’ analysis. The initial costs used in the economic evaluation alongside the ECLIPSE
trial are described in Table 1
INB incremental net benefit, LNG-IUS levonorgestrel-releasing intrauterine system, NPV net present value,
WTP willingness to pay

NPV than LNG-IUS and the incremental net benefit ex-
ceeds zero.
3.3 Response to Outcome Measure
One hundred and ten women completed and returned the
questionnaire. Both LNG-IUS and oral treatment received
the same number of non-responses (four in each). Seven
protest answers, which relate to the individual refusing to
provide a WTP value, were identified from the qualitative
explanations offered.
Ninety-nine women with an average age of 37 years
provided a WTP value for LNG-IUS and oral treatment.
LNG-IUS was the preferred treatment (47), followed by
oral treatment (39) and no preference (11). Two respon-
dents did not answer the question (see online resource for
962 S. Sanghera et al.

Fig. 1 Base-case results:

bootstrapped net present
value—oral treatment

Fig. 2 Base-case results:

bootstrapped net present
value—levonorgestrel-releasing
intrauterine system

Table 3 Sensitivity analysis: Intervention WTP Cost NPV (WTP - cost) [95 % CI] INB (NPV oral - NPV LNG-IUS)
mean WTP and cost of
treatment LNG-IUS £365 £260 £106 [£-10 to £221]
Oral treatment £372 £98 £274 [£168 to £380] £168
Mean difference £-7 £162
CI confidence interval, INB incremental net benefit, LNG-IUS levonorgestrel-releasing intrauterine system,
NPV net present value, WTP willingness to pay
Cost data are reported in UK (£) sterling and the cost year is 2011. Costs are rounded to the nearest whole
number

further information). Eighty percent of women said they
had experience of heavy periods at one time in their lives,
but this may not necessarily mean experience of heavy
periods over consecutive cycles as defined by menorrhagia.
The two most commonly cited reasons for a WTP value
were related to the ‘effect of the treatment’ and ‘afford-
ability’. There were three respondents that misunderstood
the WTP question.
Over 60 % of women who completed at least one WTP
question said that the question was not difficult to answer.
Of those who did find the question difficult to answer, the
most common reason was related to ‘not being used to
valuing healthcare’. For those who did not find the val-
uation difficult, the most commonly cited reason was ‘a
reasonable amount to pay for the expected benefits’.
4 Discussion
Over a 24-month time horizon, the total cost of oral
treatment is cheaper than LNG-IUS (£326 compared with
£433 respectively). The NPV of oral treatment is greater
than LNG-IUS (£45 compared with £-68, respectively).
Thus, oral treatment produced a positive incremental net
Exploring Cost-Benefit Analysis in Menorrhagia
benefit (equal to £113). On the basis of these results, oral
treatment could be recommended as the first-line treatment
for menorrhagia.
The findings from both sensitivity analyses support the
base-case analysis. The bootstrapped plots in sensitivity
analysis 1 demonstrate that oral treatment is the most likely
treatment to be cost beneficial. In sensitivity analysis 2,
where cost data are not taken from the ECLIPSE trial de-
cision model, which used intention-to-treat analysis but
instead relate to the exclusive use of either LNG-IUS or
oral treatment, both oral treatment and LNG-IUS generated
a positive NPV of £274 and £106 respectively. However,
oral treatment yielded the maximum NPV and therefore
was still indicated to be the most efficient choice.
Therefore, the base-case analysis and sensitivity ana-
lyses suggest that oral treatment is the most cost-beneficial
treatment and therefore should be recommended as the
first-choice treatment for menorrhagia in clinical practice.
In a privately financed healthcare system, the resource
allocation decision from a cost-benefit analysis is relatively
straightforward as a positive NPV indicates that the inter-
vention(s) be recommended for use in practice. In contrast,
when making resource allocation decisions in a publicly
funded healthcare system where a budget constraint exists,
it is unlikely to be feasible that all interventions with a
positive NPV are recommended for clinical practice [18].
Under budget constraints, the aim is to maximise benefits
and therefore the interventions could be ranked against one
another and the intervention with the greatest NPV im-
plemented [9]. Whilst this issue is not resolved, in this
case, we adopted the decision rule that the treatment choice
that yields the maximum NPV is the most efficient and
should be implemented.
4.1 Strengths and Limitations
This is the first study, to our knowledge, that applies a
cost-benefit analysis to compare LNG-IUS against oral
treatment in menorrhagia. Furthermore, a cost-benefit
analysis is rarely conducted and reported in the literature
and a strength of the current analysis, is that it is based on
WTP values that have been elicited from the ex-ante
perspective, which is theoretically preferred [9]. An ad-
ditional strength is that once the questionnaires were de-
veloped, they were checked by clinical experts in
menorrhagia, by psychologists and external health econ-
omists to assess and improve their face and content va-
lidity. Thus, rather than basing the ex-ante questionnaire
scenarios, for menorrhagia and treatment effectiveness,
on expert opinion alone or expected outcomes, novel
methods were used to base the scenarios on observed
evidence from the ECLIPSE trial, which increases the
reliability of the findings.
963
A limitation of the exploratory study is that we did not
determine how many women from our convenience sample
had experience of the treatments for menorrhagia. This
information would help to determine the extent to which
our sample reflects a true ex-ante perspective. The sample
used does to some extent reflect the ‘at-risk’ population
group, which would be made up of both women who have,
and do not have, the condition. However, where women
have experience of both menorrhagia and its treatments this
does not strictly meet the ex-ante criterion.
The costs for the base-case analysis were taken from the
average results of a trial-based economic evaluation to
enable comparability between that cost-utility analysis and
our cost-benefit analysis [6]. A potential limitation of this
approach is that the possibility of changing and stopping
treatment was not presented in the WTP scenario and
therefore would not have been considered when providing
a WTP value. However, when using cost data that are only
related to the WTP scenario the same treatment was found
to be superior. In this case, although the overall cost-benefit
decision did not differ, the extent of the welfare gain
produced by oral treatment compared with LNG-IUS did
vary, and was dependent on the cost data used in the cost-
benefit analysis.
It was not possible to conduct a comprehensive cost-benefit
analysis because societal costs were not available. Only
healthcare costs were considered in this evaluation. The dif-
fering perspectives across costs and benefits could bias the
results in favour of the benefits of the treatments as a broader
perspective is used. However, when assessing incremental net
present values across treatments, the impact is limited as the
same approach is applied to both interventions assessed. In-
corporating societal costs, such as lost productivity and out-of-
pocket prescription fees, would not be straightforward be-
cause of double counting. Arguably, the WTP outcome al-
ready incorporates lost productivity as the WTP scenarios
included impact on work/daily routine. Therefore, if changes
in productivity are also counted on the cost side of the equa-
tion, it is possible that the benefits of treatment are double
counted [19]. The other aspect of societal cost is the cost of
prescriptions, which would only be relevant to oral treatment
and the exclusion of this could be considered as bias in favour
of oral treatment. However, we estimate this cost to be small
and unlikely to change the treatment recommendation.
Finally, we recognise the limitation associated with re-
porting costs in the 2011 price year and WTP values in
2013. Different years of valuation are not unusual in health
economics as the utility values derived from other standard
measures such as EQ-5D, which is based on time trade-off
preference values from the 1990s, are similarly not derived
during the same year as costs but are presented in the same
economic evaluation. Between these two particular price
years, inflation has been particularly low and therefore the
964
lack of adjustment would introduce little if any bias. Fur-
thermore, by not changing the cost year we have presented
results that are directly comparable to the cost utility
analysis results.
Given the limited availability of cost-benefit analyses
currently reported in the literature, a strength of the current
article is that we have reported all relevant methods and
results as explicitly as possible including additional infor-
mation to that which is required by recommended guide-
lines, such as CHEERS, to which published economic
evaluations are typically recommended to adhere. As far as
we are aware, the current study is the first cost-benefit
analysis to attempt to follow CHEERS guidelines [8] and
the shortcomings of those guidelines in terms of their
relevance to the full and clear reporting of economic
evaluations that take the form of a cost-benefit analysis
have been apparent.
4.2 Comparison with Other Studies
Very few cost-benefit analyses have been published. To the
best of our knowledge, this is the only cost-benefit analysis
focussing on menorrhagia. A recent cost-benefit analysis
has been carried out but in the area of spinal surgery in
Switzerland, where WTP was elicited from the ex-post
perspective using patient values [20]. The authors sug-
gested that further methodological work be carried out on
the use of ex-ante WTP values, as this perspective is rec-
ommended for publicly funded healthcare systems. Despite
the ex-ante perspective WTP and cost-benefit analysis be-
ing theoretically preferred [9], WTP is typically elicited
from the ex-post perspective [21].
In terms of comparisons with other UK studies reporting
treatment recommendations for menorrhagia, in contrast to
our findings, the NICE guidelines recommend LNG-IUS as
the first-line treatment for menorrhagia [4]. Similarly, the
economic evaluation alongside the ECLIPSE trial using
EQ-5D also found LNG-IUS the most cost-effective in-
tervention [6]. However, the recommendation for oral
treatment to be first-line treatment in our cost-benefit
analysis does correspond with the recommendation from
the economic evaluation alongside the ECLIPSE trial using
SF-6D [6]. Decision makers currently recommend EQ-5D
for the valuation of outcomes [1], therefore LNG-IUS
would be considered the most cost-effective treatment,
despite other measures demonstrating that LNG-IUS is not
the most cost-effective intervention.
4.3 Implications and Further Research
The results of the current analysis are not attempting to
overturn the NICE guideline recommendation but instead
present an exploration of the use of an alternative measure.
S. Sanghera et al.
The results of this analysis present potentially important issues
about the use of the conventional measures from the extra-
welfarist perspective, EQ-5D and SF-6D, within the context of
decision making for certain diseases such as menorrhagia. The
cost-benefit analysis approach showed oral treatment to be the
most efficient use of society’s resources. We have previously
shown [6] that the type of measure used to value outcomes has
important implications for recommendations to decision
makers. To improve the generalisability and robustness of the
results, more research needs to be conducted using the WTP
approach on a larger sample size that more closely resembles
the general population.
Further research to explore the role of cost-benefit
analysis and the use of the welfarist approach for certain
conditions that affect non-health aspects of quality of life is
required both generally by methodologists and specifically
in applied research for clinical conditions, such as
menorrhagia.
Ethics Ethical approval was obtained from the National Research
Ethics Service Committee South West—Exeter. The research was
therefore performed in accordance with the ethical standards outlined
in the 1964 Declaration of Helsinki.Written consent was obtained
from the participants prior to their inclusion in the study.
Acknowledgments We thank the women who participated in the
study and the National Institute for Health Research for funding the
research (Grant No: 02/06/02). J. K. Gupta reports honoraria received
from Bayer (UK), the manufacturer of LNG-IUS (Mirena). All other
authors report no conflicts of interest.
Author Contributions SS, EF and TR conceived and designed the
study. SS developed and administered the questionnaire, carried out
the data analysis, conducted the CBA and wrote the manuscript. EF
and TR supported the questionnaire development and analysis. JG and
JK facilitated data collection. All authors edited the manuscript. SS,
EF and TR are the guarantors of this work.
Open Access This article is distributed under the terms of the
Creative Commons Attribution-NonCommercial 4.0 International
License (http://creativecommons.org/licenses/by-nc/4.0/), which per-
mits any noncommercial use, distribution, and reproduction in any
medium, provided you give appropriate credit to the original author(s)
and the source, provide a link to the Creative Commons license, and
indicate if changes were made.
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